FDA Regulation Compliance with BarTender

BarTender® enterprise labeling software transforms information into the labels, barcodes and RFID that drive 21 CFR Part 11 labeling compliance in FDA- and EC-validated installations at medical device and pharmaceutical companies around the world.

Global change management in an instant.

The agility to meet changes in regulation, product or process with BarTender’s Intelligent Templates™. Edit a label’s data, format or design — updates occur immediately throughout your organization. Your label is ready to print, in real time, anywhere in the world it’s needed.

Configurable, role-based access to secure labeling.

You control all access to label design and modification, database setup, document saving and printing from a central location onsite — or at a facility on the other side of the world. Apply label format encryption to any of the security levels, providing the ultimate in protection against unauthorized use.

Always know who worked with your files. 

Regulators want you to know who’s edited and printed your labels. BarTender manages electronic signatures, and brings full audit trail accountability with comprehensive data logging capabilities, from print history to versioning.

Regulatory labeling should be on-brand.

BarTender’s simple design interface and superior graphics handling — including full color capabilities — means you can design your labels to match your company’s marketing and production needs.

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